Sumamed powder for oral suspension 100mg/5ml 20.925g Strawberry vial, 1pc

Composition

In 1 gram of powder:

azithromycin dihydrate – 25.047 mg, which corresponds to the content of azithromycin-23.895 mg

Excipients:

sucrose-929.753 mg,

sodium phosphate-20 mg,

giprolose-1.6 mg,

xanthan gum-1.6 mg,

strawberry flavor-10 mg,

titanium dioxide-5 mg,

colloidal silicon dioxide-7 mg

Pharmacological action

Pharmacological action – broad-spectrum antibacterial.

Azithromycin is a broad-spectrum bacteriostatic antibiotic from the group of macrolides-azalides. It has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of microbial cell protein synthesis. Binding to the 50S subunit of the ribosome, it inhibits peptidtranslase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.

It has activity against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms. Microorganisms may initially be resistant to the action of an antibiotic or may become resistant to it.

In most cases, sensitive microorganisms: aerobic gram-positive — Staphylococcus aureus(methicillinsusceptible strains), Streptococcus pneumoniae (penicillinsusceptible strains), Streptococcus pyogenes; gram-negative aerobes — Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic bacteria — Clostridium perfringens, Fusobacterium spp. , Prevotella spp. , Porphyromonas spp. ; other micro — organisms Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms capable of developing resistance to azithromycin: gram-positive aerobes-Streptococcus pneumoniae (penicillin-resistant strains).

Initially resistant microorganisms: gram-positive aerobes-Enterococcus faecalis, Staphylococci(methicillin-resistant strains with a very high frequency have acquired resistance to macrolides), gram-positive bacteria resistant to erythromycin; anaerobic microorganisms.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

— infections of the upper respiratory tract and ENT organs (pharyngitis/tonsillitis, sinusitis, otitis media);

— infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens);

infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, acne vulgaris moderate severity (for tablets));

— initial stage of Lyme disease (borreliosis) is a migratory erythema (erythema migrans);

— infections of the urinary tract (urethritis, cervicitis), caused by Chlamydia trachomatis (for tablets and capsules).

Use during pregnancy and lactation

During pregnancy and lactation, the use of the drug is possible only if the expected potential benefit of therapy for the mother exceeds the potential risk to the fetus and child.

If it is necessary to use the drug during lactation, breastfeeding should be suspended.

WHO recommends azithromycin as the drug of choice for the treatment of chlamydia infection in pregnant women.

Contraindications

of liver severe degree

of renal dysfunction severe (CC < 40 ml/min);

— concomitant use with ergotamine and dihydroergotamine;

— children’s age up to 12 years with body weight <45 kg (for capsules and tablets of 500 mg);

— children’s age up to 3 years (for tablets 125 mg);

— children’s age up to 6 months (powder for suspension);

— deficiency of sucrase/isomaltase, fructose intolerance, glucose-galactose malabsorption (powder for suspension);

— hypersensitivity to azithromycin, erythromycin, other macrolides, or ketolides, or other components of the drug.

With caution:

Myasthenia gravis; mild to moderate hepatic impairment; mild to moderate renal impairment (creatinine clearance >40 ml/min); in patients with proarrhythmogenic factors (especially in the elderly) – with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic agents of classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water and electrolyte balance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia or severe heart failure; with simultaneous use of digoxin, warfarin, cyclosporine; diabetes mellitus (for powder for suspension preparation).

Side effects

The frequency of side effects is classified according to WHO recommendations: very common (≥10%), common (≥1%-<10%), infrequently (≥0.1%-<1%), rarely (≥0.01%-<0.1%), very rare (

Infectious diseases: infrequently-candidiasis (including oral and genital mucosa), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency-pseudomembranous colitis.

Blood and lymphatic system disorders:  infrequently-leukopenia, neutropenia, eosinophilia; very rarely – thrombocytopenia, hemolytic anemia.

From the side of metabolism: infrequently – anorexia.

Allergic reactions:  infrequently-angioedema, hypersensitivity reaction; unknown frequency – anaphylactic reaction.

Nervous system disorders:  often-headache; infrequently-dizziness, impaired taste sensations, paresthesia, drowsiness, insomnia, nervousness; rarely-agitation; unknown frequency-hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste sensations, myasthenia gravis, delusions, hallucinations.

From the side of the visual organ:  infrequently-visual impairment.

Hearing disorders and labyrinth disorders:  infrequently – hearing disorder, vertigo; unknown frequency – hearing impairment up to deafness and / or tinnitus.

From the cardiovascular system:  infrequently-palpitations, flushes of blood to the face; unknown frequency-decrease in blood pressure, increase in the QT interval on the ECG, arrhythmia of the “pirouette” type, ventricular tachycardia.

Respiratory system disorders: infrequently-shortness of breath, nosebleeds.

From the digestive system:  very often – diarrhea; often-nausea, vomiting, abdominal pain; infrequently-flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, ulcers of the oral mucosa, increased salivary gland secretion; very rarely – discoloration of the tongue, pancreatitis.

Liver and biliary tract disorders:  infrequently – hepatitis; rarely-liver dysfunction, cholestatic jaundice; unknown frequency-liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction), liver necrosis, fulminant hepatitis.

Skin and subcutaneous tissue disorders:  infrequently-skin rash, dermatitis, dry skin, sweating; rarely-photosensitization reaction; unknown frequency-Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

Musculoskeletal disorders: infrequently-osteoarthritis, myalgia, back pain, neck pain; unknown frequency-arthralgia.

From the side of the kidneys and urinary tract:  infrequently-dysuria, pain in the kidney area; unknown frequency-interstitial nephritis, acute renal failure.

From the genitals and breast:  infrequently – metrorrhagia, testicular dysfunction.

Other services: infrequently-asthenia, malaise, fatigue, facial swelling, chest pain, fever, peripheral edema.

Laboratory data: often, a decrease in the number of lymphocytes, increase in the number of eosinophils, increased number of basophils, increased number of monocytes, increasing the number of neutrophils, reducing the concentration of bicarbonate in the blood plasma; rarely – increased activity of AST, ALT, increasing the concentration of bilirubin in plasmawave, increasing the concentration of urea in blood plasma, increasing the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, increased activity of alkaline phosphatase in blood plasma, increasing chlorine content in blood plasma, increasing the concentration of glucose in the blood, increasing the number of platelets, increased hematocrit, increasing the concentration of bicarbonate in the blood plasma, a change in the content of sodium in the blood plasma.

Interaction

Antacid medications

Antacids do not affect the bioavailability of azithromycin, but reduce the Cmax in the blood by 30%, so Sumamed® should be taken at least 1 hour before or 2 hours after taking these drugs and eating.

Cetirizine

Concomitant use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to a pharmacokinetic interaction and a significant change in the QT interval.

Didanosine (dideoxyinosine)

Concomitant use of azithromycin (1200 mg / day) and didanosine (400 mg / day) There were no changes in the pharmacokinetic parameters of didanosine in 6 HIV-infected patients compared to the placebo group.

Digoxin (P-glycoprotein substrates)

Concomitant use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to an increase in the concentration of the P-glycoprotein substrate in the blood serum. Thus, when azithromycin and digoxin are used simultaneously, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

Concomitant use of azithromycin (a single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has little effect on the pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.

Azithromycin weakly interacts with cytochrome P450 isoenzymes. Azithromycin was not found to be involved in a pharmacokinetic interaction similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.

Ergot alkaloids

Given the theoretical possibility of ergotism, concomitant use of azithromycin with ergot alkaloid derivatives is not recommended.

Pharmacokinetic studies have been conducted on the concomitant use of azithromycin and drugs that are metabolized with the participation of cytochrome P450 isoenzymes.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in plasma concentrations of atorvastatin (based on the analysis of MMC-CoA reductase inhibition). However, in the post-marketing period, there have been isolated reports of rhabdomyolysis in patients receiving concomitant azithromycin and statins.

Carbamazepine

Pharmacokinetic studies in healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.

Cimetidine

In pharmacokinetic studies of the effect of cimetidine in a single dose on the pharmacokinetics of azithromycin, there were no changes in the pharmacokinetics of azithromycin, provided that cimetidine was used 2 hours before azithromycin.

Indirect anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin when taken in a single dose of 15 mg in healthy volunteers. Potentiation of the anticoagulant effect has been reported after concomitant use of azithromycin and indirect anticoagulants (coumarin derivatives). Although no causal relationship has been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving oral indirect anticoagulants (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) and then cyclosporine (10 mg/kg/day once) orally for 3 days, a significant increase in plasma Cmax and AUC0-5 of cyclosporine was detected. Caution is required with this combination. If the concomitant use of these drugs is necessary, the concentration of cyclosporine in the blood plasma should be monitored and the dose adjusted accordingly.

Efavirenz

Concomitant use of azithromycin (600 mg / day once) and efavirenz (400 mg/day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.

Fluconazole

Concomitant use of azithromycin (1200 mg once) did not alter the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1 / 2 of azithromycin did not change with concomitant use of fluconazole, but a decrease in the Cmax of azithromycin (by 18%) was observed, which was not clinically significant.

Indinavir

Concomitant use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days).

Methylprednisolone

Azithromycin has no significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir

Concomitant use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the Css of azithromycin in blood plasma. No clinically significant side effects were observed and no dose adjustment of azithromycin is required when co-administered with nelfinavir.

Rifabutin

Concomitant use of azithromycin and rifabutin does not affect the concentration of each drug in the blood plasma. Neutropenia has sometimes been observed with concomitant use of azithromycin and rifabutin. Although neutropenia has been associated with rifabutin use, a causal relationship between the use of azithromycin and rifabutin combination and neutropenia has not been established.

Sildenafil

When used in healthy volunteers, there was no evidence of the effect of azithromycin (500 mg / day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.

Terfenadine

In pharmacokinetic studies, there was no evidence of an interaction between azithromycin and terfenadine. Isolated cases were reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction took place. Concomitant use of terfenadine and macrolides has been shown to cause arrhythmia and prolongation of the QT interval.

Theophylline

There was no interaction between azithromycin and theophylline.

Triazolam / midazolam

There were no significant changes in pharmacokinetic parameters when azithromycin was co-administered with triazolam or midazolam at therapeutic doses.

Trimethoprim / sulfamethoxazole

When trimethoprim / sulfamethoxazole was co-administered with azithromycin, there was no significant effect on Cmax, total exposure, or renal excretion of trimethoprim or sulfamethoxazole. Serum concentrations of azithromycin were consistent with those found in other studies.

How to take, course of use and dosage

Inside,1 time a day,1 hour before or 2 hours after meals. After taking Sumamed® the child should definitely be offered to drink a few sips of water so that he can swallow the remains of the suspension.

Before each dose of the drug, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. If the required volume of suspension has not been removed from the vial within 20 minutes after shaking, the suspension should be shaken again, the required volume taken and given to the child.

The required dose is measured using a dosing syringe with a division price of 1 ml and a nominal suspension capacity of 5 ml (100 mg of azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (50 mg of azithromycin) or 5 ml (100 mg of azithromycin), enclosed in a cardboard package together with the bottle.

After use, the syringe (after disassembling it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next use of Sumamed®.

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: the drug is prescribed at the rate of 10 mg / kg 1 time a day for 3 days; the course dose is 30 mg / kg.

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: symptomatic therapy.

Special instructions

If you miss taking one dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.

Sumamed should be taken at least 1 hour before or 2 hours after taking antacids.

Sumamed should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe hepatic insufficiency. In the presence of symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, darkening of the urine, tendency to bleeding, hepatic encephalopathy, therapy with Sumamed® should be discontinued and a study of the functional state of the liver should be conducted.

In patients with mild to moderate renal impairment (creatinine clearance > 40 ml/min), Sumamed® therapy should be performed with caution under the control of renal function.

As with other antibacterial agents, patients with Sumamed should be regularly evaluated for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

Sumamed®preparation it should not be used for longer courses than indicated in the instructions, because the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

There are no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism when macrolides are used simultaneously with ergotamine and dihydroergotamine derivatives, this combination is not recommended.

When taking Sumamed®for a long time Pseudomembranous colitis caused by Clostridium difficile may develop in both mild diarrhea and severe colitis. Pseudomembranous colitis should be excluded if antibiotic-associated diarrhea develops while taking Sumamed®, as well as 2 months after the end of therapy.

When treated with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval was observed, which increases the risk of developing cardiac arrhythmias, including pirouette-type arrhythmias.

Caution should be exercised when using Sumamed® in patients with proarrhythmogenic factors (especially in elderly patients), including those with congenital or acquired prolongation of the QT interval; in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and others). levofloxacin), in patients with impaired water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

Use of Sumamed® it can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

When used in patients with diabetes mellitus, as well as in patients who follow a low-calorie diet, it should be taken into account that the powder for the preparation of Sumamed® suspension contains sucrose (0.32 XE/5 ml) as an auxiliary substance.

Influence on the ability to drive motor vehicles and manage mechanisms

With the development of undesirable effects from the nervous system and the visual organ, care should be taken when performing actions that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Keep out of reach of children at temperatures between 15° and 25°C.

Shelf

life is 2 years. The shelf life of the prepared suspension is 5 days.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor, Children as prescribed by a doctor

Indications

Respiratory Tract Infections, Skin Infections, Pharyngitis, Urethritis, Otitis Media, Bronchitis, Sinusitis, Infectious Diseases, Tonsillitis, Pneumonia, Sore Throat